Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 30, 2016
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pentax of America Inc recalled Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including … - a moderate-severity action.
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including … was recalled by Pentax of America Inc in November 30, 2016. Reason: Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shippe…. Check the official notice for the remedy. Verify recall #Z-0636-2017 with the FDA Devices before acting.
The recall
Pentax of America Inc issued this moderate-severity FDA Devices recall-Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shippe….
- Moderate
- severity level
- Class II
- classification
- November 30, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0636-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0636-2017) was formally reported on November 30, 2016, with the manufacturer initiating the action on August 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Pentax of America Inc is listed as the recalling firm, operating out of Montvale, NJ. Federal records list the affected scope as 5,090 (US) and 14,209 (OUS).
The documented reason for this recall is: Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocess… Distribution data in the federal record shows the product reached: US Nationwide and Japan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,090 (US) and 14,209 (OUS)
Related Recalls
6
3 from same agency
Product description
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Reason for recall
Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0636-2017 |
| Date reported | November 30, 2016 |
| Date initiated | August 15, 2016 |
| Recalling firm | Pentax of America Inc |
| Firm location | Montvale, NJ |
| Affected scope | 5,090 (US) and 14,209 (OUS) |
| Distribution | US Nationwide and Japan |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0636-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.. Recalled by Pentax of America Inc. Units affected: 5,090 (US) and 14,209 (OUS).
Why was this product recalled? ▼
Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0636-2017.
Where was the recalled product distributed? ▼
Distribution: US Nationwide and Japan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0636-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 30, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.